Effectiveness of add-on group behavioral activation treatment for depression in psychiatric care

• Register: ISRCTN
• Last refreshed on: 28 November 2016
• Main ID: ISRCTN10647845
• Date of registration: 26/10/2016
• Prospective Registration: No
• Primary sponsor: University of Helsinki and Helsinki University Hospital
• Public title: Effectiveness of add-on group behavioral activation treatment for depression in psychiatric care
• Scientific title: Effectiveness of group format behavioral activation treatment for depression or peer support groups added on usual treatment vs treatment as usual for depression in psychiatric care
• Date of first enrolment: 07/09/2016
• Target sample size: 288
• Recruitment status: Completed
• URL: http://isrctn.com/ISRCTN10647845
• Study type: Interventional
• Study design: Randomized three-arm parallel-group study (Treatment)

Countries of recruitment

Finland

Contacts

• Name: Erkki Isometsä

Key inclusion & exclusion criteria

Inclusion criteria: 1. Psychiatric outpatient at the Helsinki University Hospital Department of Psychiatry Mood Disorder Division
2. DSM-5 major depressive disorder
3. Fluency in Finnish
4. Age 18-65
Exclusion criteria: 1. Psychotic features
2. Chronic major depressive disorder (uninterrupted duration > 2 years)
3. Principal clinical diagnosis borderline personality disorder
4. Principal clinical diagnosis substance use disorder
5. Imminent threat of suicide
6. Need of psychiatric hospitalization
7. Any illness or symptom hampering participation in the treatments
8. Other ongoing weekly psychotherapy

Age minimum:
Age maximum:
Gender: Both

Health Condition(s) or Problem(s) studied

Major depressive disorder
Mental and Behavioural Disorders

Intervention(s)

Participants are randomised to one of three treatments:
1. Treatment as usual, plus behavioral activation treatment for depression (BATD) in group format weekly for 8 weeks at the premises of the outpatient clinic. The sessions last 90 minutes and are delivered by two therapists who are experienced mental health professionals (mostly psychiatric nurses or psychologists).
2. Treatment as usual, plus group peer support weekly for 8 weeks, in which a group of patients regularly meet to discuss their problems at the premises of the outpatient clinic, facilitated by an expert by experience having recovered from depression and received brief training for the task by Finnish Central Association for Mental Health. The sessions last 90 minutes, and one psychiatric nurse participates in the session, but does not have an active facilitator role.
3. Treatment as usual, mostly comprising antidepressant pharmacotherapy and low-intensity psychotherapeutic support provided by a specialized nurse. Number of visits not predefined.

In all groups, symptoms are evaluated before the first session or visit after randomization in the TAU group, and 8 weeks later (primary outcome 8-week PHQ-9). Six months after the end of intervention, there is a follow-up measurement using the PHQ-9 (one of the secondary outcomes).

Primary Outcome(s)

Depression score, measured using the Patient Health Questionnaire (PHQ-9) at baseline and after the 8-week intervention

Secondary Outcome(s)

1. Response, defined as = 50% decline in PHQ-9 score, measured at 8 weeks
2. Remission, defined as PHQ-9 score < 5, measured at 8 weeks
3. Functional impairment, measured using the Sheehan Disability Scale Score at baseline and 8 weeks
4. Depression score, measured using the PHQ-9 at baseline and 6 months after the intervention

Secondary ID(s)

N/A

Source(s) of Monetary Support

Helsinki and Uusimaa Hospital District